In controlled trials used to support the efficacy of
fluoxetine, patients were administered morning doses ranging from 20 to 80
mg/day. Studies comparing fluoxetine 20, 40, and 60 mg/day to placebo indicate
that 20 mg/day is sufficient to obtain a satisfactory response in Major
Depressive Disorder in most cases [see Clinical Studies].

Pediatric (children and adolescents) — Initiate
PROZAC 10 or 20 mg/day. After 1 week at 10 mg/day, increase the dose to 20
mg/day. However, due to higher plasma levels in lower weight children, the
starting and target dose in this group may be 10 mg/day. Consider a dose
increase to 20 mg/day after several weeks if insufficient clinical improvement is
observed. In the short-term (8 to 9 week) controlled clinical trials of
fluoxetine supporting its effectiveness in the treatment of Major Depressive
Disorder, patients were administered fluoxetine doses of 10 to 20 mg/day [seeClinical Studies].

All patients — As with other drugs effective in
the treatment of Major Depressive Disorder, the full effect may be delayed
until 4 weeks of treatment or longer.

Periodically reassess to determine the need for
maintenance treatment.

Switching Patients to a Tricyclic Antidepressant (TCA)
— Dosage of a TCA may need to be reduced, and plasma TCA concentrations may
need to be monitored temporarily when fluoxetine is coadministered or has been
recently discontinued [see WARNINGS AND PRECAUTIONS and DRUG
INTERACTIONS].

Obsessive Compulsive Disorder

Initial Treatment

Adult — Initiate PROZAC 20 mg/day, orally in the
morning. Consider a dose increase after several weeks if insufficient clinical
improvement is observed. The full therapeutic effect may be delayed until 5
weeks of treatment or longer. Administer doses above 20 mg/day once daily in
the morning or twice daily (i.e., morning and noon). A dose range of 20 to 60
mg/day is recommended; however, doses of up to 80 mg/day have been well
tolerated in open studies of OCD. The maximum fluoxetine dose should not exceed
80 mg/day.

In the controlled clinical trials of fluoxetine
supporting its effectiveness in the treatment of OCD, patients were administered
fixed daily doses of 20, 40, or 60 mg of fluoxetine or placebo [seeClinical
Studies]. In one of these studies, no dose-response relationship for
effectiveness was demonstrated.

Pediatric (children and adolescents) — In
adolescents and higher weight children, initiate treatment with a dose of 10
mg/day. After 2 weeks, increase the dose to 20 mg/day. Consider additional dose
increases after several more weeks if insufficient clinical improvement is
observed. A dose range of 20 to 60 mg/day is recommended.

In lower weight children, initiate treatment with a dose
of 10 mg/day. Consider additional dose increases after several more weeks if
insufficient clinical improvement is observed. A dose range of 20 to 30 mg/day
is recommended. Experience with daily doses greater than 20 mg is very
minimal, and there is no experience with doses greater than 60 mg.

In the controlled clinical trial of fluoxetine supporting
its effectiveness in the treatment of OCD, patients were administered
fluoxetine doses in the range of 10 to 60 mg/day [seeClinical Studies].

Periodically reassess to determine the need for
treatment.

Bulimia Nervosa

Initial Treatment — Administer PROZAC 60 mg/day in
the morning. For some patients it may be advisable to titrate up to this target
dose over several days. Fluoxetine doses above 60 mg/day have not been
systematically studied in patients with bulimia. In the controlled clinical
trials of fluoxetine supporting its effectiveness in the treatment of Bulimia Nervosa,
patients were administered fixed daily fluoxetine doses of 20 or 60 mg, or
placebo [see Clinical Studies]. Only the 60 mg dose was statistically
significantly superior to placebo in reducing the frequency of binge-eating and
vomiting.

Periodically reassess to determine the need for
maintenance treatment.

Panic Disorder

Initial Treatment — Initiate treatment with PROZAC
10 mg/day. After one week, increase the dose to 20 mg/day. Consider a dose
increase after several weeks if no clinical improvement is observed. Fluoxetine
doses above 60 mg/day have not been systematically evaluated in patients with
Panic Disorder. In the controlled clinical trials of fluoxetine supporting its
effectiveness in the treatment of Panic Disorder, patients were administered
fluoxetine doses in the range of 10 to 60 mg/day [see Clinical Studies].
The most frequently administered dose in the 2 flexible-dose clinical trials was
20 mg/day.

Periodically reassess to determine the need for continued
treatment.

PROZAC And Olanzapine In Combination: Depressive Episodes
Associated With Bipolar I Disorder

When using PROZAC and olanzapine in combination, also
refer to the Clinical Studies section of the package insert for Symbyax.

Adult — Administer fluoxetine in combination with
oral olanzapine once daily in the evening, without regard to meals, generally
beginning with 5 mg of oral olanzapine and 20 mg of fluoxetine. Make dosage
adjustments, if indicated, according to efficacy and tolerability within dose
ranges of fluoxetine 20 to 50 mg and oral olanzapine 5 to 12.5 mg. Antidepressant
efficacy was demonstrated with olanzapine and fluoxetine in combination with a
dose range of olanzapine 6 to 12 mg and fluoxetine 25 to 50 mg. Safety of
co-administration of doses above 18 mg olanzapine with 75 mg fluoxetine has not
been evaluated in clinical studies. Periodically re-examine the need for continued
pharmacotherapy.

Children and adolescents (10 -17 years of age) — Administer
olanzapine and fluoxetine combination once daily in the evening, generally
beginning with 2.5 mg of olanzapine and 20 mg of fluoxetine. Make dosage
adjustments, if indicated, according to efficacy and tolerability. Safety of
co-administration of doses above 12 mg of olanzapine with 50 mg of fluoxetine
has not been evaluated in pediatric clinical studies. Periodically re-examine
the need for continued pharmacotherapy.

Safety and efficacy of fluoxetine in combination with
olanzapine was determined in clinical trials supporting approval of Symbyax
(fixed-dose combination of olanzapine and fluoxetine). Symbyax is dosed between
3 mg/25 mg (olanzapine/fluoxetine) per day and 12 mg/50 mg
(olanzapine/fluoxetine) per day. The following table demonstrates the appropriate
individual component doses of PROZAC and olanzapine versus Symbyax. Adjust
dosage, if indicated, with the individual components according to efficacy and
tolerability.

Table 1: Approximate Dose Correspondence Between
Symbyax1 and the Combination of PROZAC and Olanzapine

For

Use in Combination

Symbyax (mg/day)

Olanzapine (mg/day)

PROZAC (mg/day)

3 mg olanzapine/25 mg fluoxetine

2.5

20

6 mg olanzapine/25 mg fluoxetine

5

20

12 mg olanzapine/25 mg fluoxetine

10+2.5

20

6 mg olanzapine/50 mg fluoxetine

5

40+10

12 mg olanzapine/50 mg fluoxetine

10+2.5

40+10

1 Symbyax (olanzapine/fluoxetine HCL) is a
fixed-dose combination of PROZAC and olanzapine.

PROZAC monotherapy is not indicated for the treatment of
depressive episodes associated with Bipolar I Disorder.

PROZAC And Olanzapine In Combination: Treatment Resistant
Depression

When using PROZAC and olanzapine in combination, also
refer to the Clinical Studies section of the package insert for Symbyax.

Administer fluoxetine in combination with oral olanzapine
once daily in the evening, without regard to meals, generally beginning with 5
mg of oral olanzapine and 20 mg of fluoxetine. Adjust dosage, if indicated,
according to efficacy and tolerability within dose ranges of fluoxetine 20 to
50 mg and oral olanzapine 5 to 20 mg. Antidepressant efficacy was demonstrated
with olanzapine and fluoxetine in combination with a dose range of olanzapine 6
to 18 mg and fluoxetine 25 to 50 mg.

Safety and efficacy of fluoxetine in combination with
olanzapine was determined in clinical trials supporting approval of Symbyax
(fixed dose combination of olanzapine and fluoxetine). Symbyax is dosed between
3 mg/25 mg (olanzapine/fluoxetine) per day and 12 mg/50 mg (olanzapine/fluoxetine)
per day. Table 1 demonstrates the appropriate individual component doses of
PROZAC and olanzapine versus Symbyax. Adjust dosage, if indicated, with the
individual components according to efficacy and tolerability.

Periodically re-examine the need for continued
pharmacotherapy.

Safety of coadministration of doses above 18 mg
olanzapine with 75 mg fluoxetine has not been evaluated in clinical studies.

PROZAC monotherapy is not indicated for the treatment of
treatment resistant depression (Major Depressive Disorder in patients who do
not respond to 2 antidepressants of adequate dose and duration in the current
episode).

Dosing In Specific Populations

Treatment of Pregnant Women — When treating
pregnant women with PROZAC, the physician should carefully consider the
potential risks and potential benefits of treatment. Neonates exposed to SSRIs
or SNRIs late in the third trimester have developed complications requiring
prolonged hospitalization, respiratory support, and tube feeding [seeUse
in Specific Populations].

PROZAC and Olanzapine in Combination — Use a
starting dose of oral olanzapine 2.5 to 5 mg with fluoxetine 20 mg for patients
with a predisposition to hypotensive reactions, patients with hepatic
impairment, or patients who exhibit a combination of factors that may slow the
metabolism of olanzapine or fluoxetine in combination (female gender, geriatric
age, non-smoking status), or those patients who may be pharmacodynamically
sensitive to olanzapine. Titrate slowly and adjust dosage as needed in patients
who exhibit a combination of factors that may slow metabolism. PROZAC and olanzapine
in combination have not been systematically studied in patients over 65 years
of age or in patients less than 10 years of age [see WARNINGS AND
PRECAUTIONS and DRUG INTERACTIONS].

Discontinuation Of Treatment

Symptoms associated with discontinuation of fluoxetine,
SNRIs, and SSRIs, have been reported [see WARNINGS AND PRECAUTIONS].

Switching A Patient To Or From A Monoamine Oxidase
Inhibitor (MAOI) Intended To Treat Psychiatric Disorders

At least 14 days should elapse between discontinuation of
an MAOI intended to treat psychiatric disorders and initiation of therapy with
PROZAC. Conversely, at least 5 weeks should be allowed after stopping PROZAC
before starting an MAOI intended to treat psychiatric disorders [see CONTRAINDICATIONS].

Use Of PROZAC With Other MAOIs Such As Linezolid Or Methylene
Blue

Do not start PROZAC in a patient who is being treated
with linezolid or intravenous methylene blue because there is an increased risk
of serotonin syndrome. In a patient who requires more urgent treatment of a
psychiatric condition, other interventions, including hospitalization, should
be considered [see CONTRAINDICATIONS].

In some cases, a patient already receiving PROZAC therapy
may require urgent treatment with linezolid or intravenous methylene blue. If
acceptable alternatives to linezolid or intravenous methylene blue treatment
are not available and the potential benefits of linezolid or intravenous
methylene blue treatment are judged to outweigh the risks of serotonin syndrome
in a particular patient, PROZAC should be stopped promptly, and linezolid or
intravenous methylene blue can be administered. The patient should be monitored
for symptoms of serotonin syndrome for five weeks or until 24 hours after the
last dose of linezolid or intravenous methylene blue, whichever comes first.
Therapy with PROZAC may be resumed 24 hours after the last dose of linezolid or
intravenous methylene blue [see WARNINGS AND PRECAUTIONS].

The risk of administering methylene blue by
non-intravenous routes (such as oral tablets or by local injection) or in intravenous
doses much lower than 1 mg/kg with PROZAC is unclear. The clinician should,
nevertheless, be aware of the possibility of emergent symptoms of serotonin
syndrome with such use [see WARNINGS AND PRECAUTIONS].

HOW SUPPLIED

Dosage Forms And Strengths

10 mg Pulvule is an opaque green cap and opaque green
body, imprinted with DISTA 3104 on the cap and Prozac 10 mg on the body

20 mg Pulvule is an opaque green cap and opaque yellow
body, imprinted with DISTA 3105 on the cap and Prozac 20 mg on the body

40 mg Pulvule is an opaque green cap and opaque orange
body, imprinted with DISTA 3107 on the cap and Prozac 40 mg on the body

90 mg Prozac Weekly™ Capsule is an opaque green cap and
clear body containing discretely visible white pellets through the clear body
of the capsule, imprinted with Lilly on the cap and 3004 and 90 mg on the body

The following products are manufactured by Eli Lilly and
Company for Dista Products Company:

Pulvule are available in 10mg, 20mg and 40mg capsule
strengths and packages as follows:

Pulvule Strength

10 mg1

20 mg1

40 mg1

Pulvule No.2

PU3104

PU3105

PU3107

Cap Color

Opaque green

Opaque green

Opaque green

Body Color

Opaque green

Opaque yellow

Opaque orange

Identification

DISTA 3104 Prozac 10 mg

DISTA 3105 Prozac 20 mg

DISTA 3107 Prozac 40 mg

NDC Codes:

Bottles of 30

0777-3105-30

0777-3107-30

Bottles 100

0777-3104-02

0777-3105-02

Bottles of 2000

0777-3105-07

The following product is manufactured and distributed by
Eli Lilly and Company:

PROZAC® Weekly™ Capsules are available in:

The 90 mg1 capsule is an opaque green cap and
clear body containing discretely visible white pellets through the clear body
of the capsule, imprinted with Lilly on the cap and 3004 and 90 mg on the body.